Richard Ehrhardt wrote:The parasitologists I have contacted feel it is really just a matter of the cost of introducing this product (or any) to the USA being are too great to be recouped through sales as the USA market is too small.
Hi Richard-
I agree the lack of projected profitability envisioned by many pharmaceutical companies is a major stumbling block when it comes to introducing a product into our sheep industry compared to that of others. But it's not just because we lack the numbers. Introducing a new and novel product means overcoming the cost to gain FDA approval. Which in turn means overcoming the hurdles necessary for compounds with prolonged tissue residues and some of the other things mentioned. I don't think you can separate the two. It's a significant part of the equation, and when those two factors combined show red ink time and time again at board meetings, I suspect major pharmaceutical companies like to mention the size, (or lack of), the market and leave the political wrangling out. In the greater scheme of things, It's easier for them to deal with the negative PR from our sheep industry than it is to butt heads with an agency that can make their life miserable across the board if it wants.
It's frustrating to me that our approval process seems to be so expensive and stringent compared to other countries, yet we allow the importation of competitive products produced with the use of compounds and biologicals, (vaccines), approved under standards we wouldn't allow. Granted, when sheep is number two on the GDP list, you're bound to turn more heads when it comes to an industries ability to navigate regulatory legislation. One just has to look at the recent decision to reduce domestic sheep grazing on the Payette National Forest some 70 percent because of the falsely contrived notion that it's going to prevent exposure of native Bighorn sheep to Pasteurella pneumonia to see what the sheep industry in this country is up against.